During an inspection of your firm located in Boca Raton, Florida, on July 30, 2012, through August 3, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures heating pads. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Steve Kroeker, Senior Director, Global Quality Assurance, dated August 24, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm stated to the FDA investigator that it uses its Global Product Development Process as the design control procedure for its class II devices. However, the Global Product Development Process does not address requirements for design input, design output, design review, design validation, design transfer, and design history file for each type of device.

We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it would revise its design control procedure to make clear reference to the major subsections of design control by October 31, 2012. However, your firm did not provide any technical information and description of implementation of the correction and the corrective action for its revised design control procedure, which should also consider system corrective action.

2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, corrective and preventive action (CAPA) 10-207 is for a design change to correct overheating of the Heating Pad controller. Your firm’s short term action in CAPA 10-207, describes a change of height for the R9 resistor from (b)(4) to (b)(4). Your firm was unable to provide any design change documentation to the FDA investigator for this design change.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that the CAPA would be updated to include the design change documentation for the short term action by September 30, 2012, and that it would initiate any needed CAPAs and update CAPAs which are missing required information. However, the response did not provide any detailed information and description regarding your firm’s correction and the corrective action for its CAPA procedure and design change control procedure, which must consider system corrective action.

3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s heating pad contract manufacturer initiated a corrective action in 2008 to address reported failures of the auto shut-off feature. This action was not documented by your firm until April 12, 2010, as part of CAPA 10-202. However, your firm did not verify or validate the effectiveness of this corrective action. Specifically, following the 2008 corrective action, your firm received voluntary MedWatch reports for a heating pad manufactured on July 12, 2009, which indicated that the auto shut-off did not work. Additionally, your firm received Complaint Access #16752, dated January 4, 2012, which indicated that the 2 hour auto shut-off feature did not work on a heating pad manufactured on August 3, 2009.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that improvements had been made in 2004 to improve the cord flexing capabilities from (b)(4) cycles to (b)(4) cycles by extending the strain relief and making it more flexible. Additionally, the supplier added specific instructions to its user warnings to “loop the cord loosely when storing. Tight wrapping may damage the cord and internal parts.” However, your firm did not indicate whether it has verified or validated the effectiveness of its corrections and corrective action.

4. Failure to document all corrective and preventive action activities and their results, as required by 21 CFR 820.100(b). For example:

a. CAPA 10-207, dated April 19, 2010, regarding a design change to correct overheating of a heating pad controller is inadequate in that:

i. Your firm failed to document the cause of intermittent heating of the R9 resistor above the heat specification at the controller surface.

ii. Your firm did not document which controller was tested, where the temperature of (b)(4) was found (controller surface or resistor surface), and did not document both temperature at controller surface and resistor surface.

iii. Your firm has no documentation of the determination of whether a field action was considered with regards to CAPA 10-207.

b. Your firm completed a new design project for 2011-2020, dated October 13, 2011, to correct/prevent users from pouring water in the outlet nozzle, which could cause moisture to get into the electrical components of your firm’s humidifiers. However, this action is not documented according to your firm’s Corrective and Preventive Action procedure, CO-QA-026, Corrective and Preventive Action Processing Procedure.

We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that the humidifier instructions and warnings indicate the need for daily and weekly maintenance and that it would investigate and decide whether a corrective action should be taken. Your firm identified the auto shutoff feature as a consumer convenience, not a safety feature, and believes that no corrective action is required. Additionally, your firm’s response indicated that it would initiate any needed CAPAs and update CAPAs which are missing required information. However, your firm’s response did not provide any detailed information and description regarding the correction and the corrective action for its CAPA procedure, which must consider systemic corrective actions.

5. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s complaint handling procedure does not ensure that all complaints are processed in a timely manner, and evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting.

We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it would implement new processes and procedures for investigation, review of applicable information, and review for reportability as an MDR by October 31, 2012. However, your firm did not provide any technical information and description of implementation of the correction and the corrective action for its complaint handling procedure, which must consider systemic corrective action.

6. Failure to maintain a record of investigation, when an investigation is made under this section, by the formally designated unit identified in paragraph (a) of this section, as required by 21 CFR 820.198(e). For example, your firm failed to maintain records of the investigations in accordance with its complaint handling procedure to include the date complaints were received, complainant contact information, dates and results of the investigation, and any corrective action taken for the following complaints: Nos. 12123, 14289, 16605, 16080, 16600, and 12160.

We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it has implemented new processes and procedures to investigate, review information, and review for reportability as an MDR. These new procedures include documentation of complaint date, root cause, description of decision date, and documentation and rational for non-reportability under applicable regulations. However, your firm did not provide any technical information, description and evidence of implementation of the corrections and the corrective action for its complaint handling procedure, which must also consider systemic corrective action.

7. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:

a. Your firm’s purchasing controls do not include assurance that power cords imported from its supplier and used with its heating pads met specifications consistently, though the firm has received complaints regarding the power cords.

b. Your firm failed to complete purchasing control activities according to its purchasing control procedure, CO-QA-056, Selection and Approval of Service Supplier, Rev. A, for its software supplier responsible for software development for the (b)(4) medical device.

c. Your firm’s Supplier Quality Assessment Procedure, CO-QA-041 Rev. C, dated December 10, 2008, requires that Quality System Audit Report for Medical Device Manufacturers, CO-QA-F05 Rev. A, dated February 24, 2010, be used; however, this is inadequate in that it does not include qualification and training including inspection of and completion of manual smoldering.

e. Your firm’s most recent medical device audit of the contract manufacturer for the (b)(4) medical device in China was on December 9, 2008. This audit criteria did not include documentation that qualification and training of employees on ESD (Electrostatic Discharge) was covered during the audit.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response indicated that all power cords are UL listed components that are inspected by UL at the cord manufacturing sites on a regular basis. Your firm stated that it would modify its heating pad pre-shipment inspection plan to require a certificate of conformance from the manufacturer and traceability to the lot of power cords used for heating pads.

Additionally, the response indicates that your firm’s Service Supplier form would be modified to include specific requirements for software developers and applied to the software developer for the (b)(4) medical device. The response also indicates that the Quality System Audit Report form would be revised to include the assessment of employee training, training records for manufacturing equipment, and the evaluation of suppliers’ overall product design capabilities. The heating pad supplier would be re-audited using the revised form.

Furthermore, your firm intends to develop a controlled design guideline for the PCB layout of the R9 resistors to include design specification and review. However, your firm did not provide any technical information, description and evidence of implementation of the corrections and the corrective action for its purchasing control procedure, which must also consider systemic corrective action. Specifically, your firm did not provide the revision of the procedures associated with the purchasing control forms that would ensure that the procedures are followed.

Our inspection also revealed that your firm’s heating pad devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

1. Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:

a. Complaint Access #16753 describes an event in which the device caught fire, and as a result, the patient was burned. The burn was treated with Silvadene. Silvadene is a prescription medication (Silver sulfadiazine, a sulfa drug) that is used to prevent and treat infections of second and third-degree burns. The use of prescription medication suggests that the injury necessitated medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. No MDR was submitted for the event.

b. Complaint Access #16600, #12161, and #16752, describe events that involve your firm’s heating pads with third-degree patient burns. The information from the complaints reasonably suggests that the device may have caused or contributed to a reportable serious injury. The MDRs were not submitted to FDA within 30 calendar days of your firm becoming aware of the reportable events.

We reviewed your firm’s response and conclude that it is not adequate. Based on your firm’s response, its process for considering whether an event meets the criteria for reportability is to wait for evidence and/or the results of its investigation to demonstrate that its device has caused or contributed to the reported event. Please note that a manufacturer is required to submit MDRs to FDA no later than 30 calendar days after the day that it receives, or otherwise becomes aware of, information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a reportable event.

Also, if a death or serious injury was, or may have been attributed to your firm’s medical device, or if your firm’s medical device was or may have been a factor in a death or serious injury, including events occurring as a result of user error, the event should be reported to FDA within the required timeframes.

2. Failure of your firm to submit a report no later than 30 calendar days after the day that it received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned, and this device or similar device that it markets, would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, complaint access #11991, #14289, #10931, and #12123, reference events where your firm’s device malfunctioned (i.e. overheated). The malfunction of the device resulted in reports of fire for Complaint Access # 14289 and #10931; and additionally, for Complaint Access #11991 and #12123, the overheated device melted a hole on the device and burned a carpet, respectively.

A malfunction of a device that results in a fire or burning of contact surfaces would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. The MDRs submitted by your firm for each of the referenced complaints were not received by FDA within 30 calendar days after the day that your firm received, or otherwise became aware of information, from any source, that reasonably suggests that your firm’s device has malfunctioned and this device, or a similar device that it markets, would be likely to cause or contribute to a death or serious injury if it were to recur.

We reviewed your firm’s response and conclude that it is not adequate. Your firm does not agree that the MDRs for Complaint Access #11991, #14289, and #12123, were not submitted within the required timeframes. Your firm clarified in its response that the information for Complaint Access #11991, #14289, and #12123, was submitted to the FDA following receipt of evidence that confirmed that its device was involved in the referenced events and had malfunctioned. Please note that a manufacturer is required to submit MDRs to FDA no later than 30 calendar days after the day that it receives, or otherwise becomes aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned, and this device or a similar device that it markets, would be likely to cause or contribute to a death or serious injury if it were to recur.

If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at Reportabilityreviewteam@fda.hhs.gov.

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Refer to the Unique Identification Number 353519 when replying. If you have any questions about the contents of this letter, please contact: Andrea Norwood at 407-475-4724 or via fax 407-475-4769.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.